In Phase II-IV

PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors.

Oncology

PharmaNet’s Oncology team provides equal measure of both medical and operational expertise, with professionals from both sides working together in dedicated project teams. Medical professionals include board-certified oncologists and other oncology-experienced clinicians, with operations expertise provided by clinical research associates, project managers, data management professionals, biostatisticians, and medical writers.

 

The PharmaNet Oncology team has experience in all stages of development up to and including the registration process, as well as expertise in therapeutic modes including chemotherapy, radiotherapy, biologics, and medical devices. The team also has the depth and breadth of experience to conduct studies on any scale from regional to large, global programs. All services are available on a stand-alone basis or as part of larger drug development programs.

 

 

Along with its experience and expertise, the PharmaNet Oncology team also offers key competitive advantages:

Strong relationships with many of the world’s leading medical centers and specialists, enabling access to a large network of investigators and patient populations.
Senior-management oversight of all projects.
A collaborative approach among team members and sponsor staff to share best practices and knowledge about the competitive landscape.
The global resources to conduct programs wherever patient populations, economic conditions, and regulatory environment are most favorable.

 

 

Case Studies

1. Difficult Dosage Regimen for Metastatic Breast Cancer

2. Keeping a Small Phase I Trial on Track

3. Managing Multiple, Multinational Programs for A Single Sponsor

 


Gary E. Fishbein, MD, MPH

Senior Medical Director, Oncology

Dr. Fishbein has nearly 15 years of experience in clinical, pharmaceutical, and contract-research settings. Prior to joining PharmaNet, he was Assistant Medical Director at Ortho Biotech, monitoring clinical studies of chemotherapeutic agents. Dr. Fishbein has also served as Attending Medical Oncologist at Thomas Jefferson University Hospital and spent more than 7 years in private oncology practice.


Richard A. Nelson, MS

Vice President, Clinical Research

Mr. Nelson has 25 years of clinical research experience in both the pharmaceutical and CRO industries. At PharmaNet, he has held key positions as Vice President, Specialized Pharmaceutical Services and Senior Director, Clinical Operations Technology. Before joining PharmaNet, Mr. Nelson served as Global Project Director, Global Research and Development for the R. W. Johnson Pharmaceutical Research Institute (PRI). In that position, he developed infrastructure to support global clinical trials, including programs in Japan, Brazil, Argentina, South Africa, Eastern and Western Europe, as well as throughout the former Soviet republics. Other key positions in his career include Assistant Director, Oncology Project Planning at Janssen Research Foundation, and Manager, Hematology/Oncology Clinical Research at R. W. Johnson PRI. Mr. Nelson achieved both his BS in physiology and MS in microbiology/immunology at Rutgers University.


Manuela Niewel, MD

Senior Medical Director, Oncology, Medical and Scientific Affairs

Dr. Niewel is a Medical Oncologist with more than 15 years of experience in the pharmaceutical and contract research industries. She has been involved in the management and conduct of clinical trial programs throughout her career and was the Medical Director and Chief Scientific Officer at an oncology-specific clinical research company prior to joining PharmaNet.


Ann Sysel, MD

Executive Medical Director, Oncology, Medical and Scientific Affairs

Dr. Sysel has experience in preclinical and clinical research. Her areas of expertise include medical oncology, hematology, and supportive care of the oncology patient. Dr. Sysel has additional training in epidemiology, and her work experience includes programs in high-dose chemotherapy, and autologous stem cell transplantation, among others.

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390